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Combination Method Using Sodium Picosulfate and Magnesium Citrate and PEG With Ascorbic Acid for Bowel Preparation

Sponsor
National Cancer Center, Korea (Other)
Overall Status
Completed
CT.gov ID
NCT02979223
Collaborator
(none)
142
Enrollment
1
Location
2
Arms
7
Duration (Months)
20.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The aim of this study is to compare the efficacy depending on the order of the sequential combination method using sodium picosulfate and magnesium citrate (PMC) and PEG with ascorbic acid for bowel preparation.

The investigators designed this study as a phase II prospective randomized parallel arm clinical trial. 71 participant will be enrolled in each group (142 in total).

The primary outcome is the efficacy of bowel preparation. secondary outcomes are tolerability, side effect of the drugs, polyp detection rate and adenoma detection rate.

Condition or Disease Intervention/Treatment Phase
  • Drug: sodium picosulfate and magnesium citrate, polyethylene glycol with ascorbic acid
 Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
142 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Investigator)
Primary Purpose:
Diagnostic
Official Title:
Comparison the Efficacy Depending on the Order of the Sequential Combination Method Using Sodium Picosulfate and Magnesium Citrate (PMC) and PEG With Ascorbic Acid for Bowel Preparation (The Phase II Prospective Randomized Clinical Trial)
Study Start Date :
Nov 1, 2016
Actual Primary Completion Date :
Jun 1, 2017
Actual Study Completion Date :
Jun 1, 2017

Arms and Interventions

Arm Intervention/Treatment
Experimental: PMC/PEG-Asc

Picolyte 1 bottle/170cc at one day before colonoscopy, 7 PM. And then, Intake Coolprep 1L at the day of colonoscopy, 5 AM

Drug: sodium picosulfate and magnesium citrate, polyethylene glycol with ascorbic acid
sodium picosulfate and magnesium citrate and 2L polyethylene glycol with ascorbic acid are used as combination method. There is a difference in the order of intake between two group
Other Names:
  • Picosolution
  • Coolprep

    		•
    Active Comparator: PEG-Asc/PMC

    Intake Coolprep 1L at one day before colonoscopy, 7 PM. And then, Intake Picolyte 1 bottle/170cc at the day of colonoscopy, 5AM

    Drug: sodium picosulfate and magnesium citrate, polyethylene glycol with ascorbic acid
    sodium picosulfate and magnesium citrate and 2L polyethylene glycol with ascorbic acid are used as combination method. There is a difference in the order of intake between two group
    Other Names:
  • Picosolution
  • Coolprep

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Successful bowel preparation (Excellent and Good in Aronchick bowel preparation score) [during colonoscopy]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 70 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • Age: 20-75 Patients who visited the outpatient clinic for colonoscopy Patients who agreed to participate in this study
    Exclusion Criteria:
    • pregnancy, breast feeding stage 3-5 chronic kidney disease (glomerular filtration rate < 60 mL/min/1.73m2), inability to maintain adequate fluid intake, pre-existing electrolyte disturbances, symptomatic congestive heart failure, recent (within < 6 months) symptomatic ischemic heart disease (unstable angina or myocardial infarction).

    toxic megacolon active colitis Allergic to drug altered mental status Nausea and vomiting Hyperphosphatemia glucose-6-phosphate dehydrogenase deficiency Hereditary Phenylketonuria Patients with a history of colon surgery Abdominal operation within 6 months

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Bun Kim Goyang Gyeonggi-do Korea, Republic of 10408

    Sponsors and Collaborators

    • National Cancer Center, Korea

    Investigators

    • Principal Investigator: Bun Kim, Dr, National Cancer Center, Korea

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Byung Chang KIM, Principle investigator, National Cancer Center, Korea
    ClinicalTrials.gov Identifier:
    NCT02979223
    Other Study ID Numbers:
    • NCC2016-0166
    First Posted:
    Dec 1, 2016
    Last Update Posted:
    Aug 28, 2019
    Last Verified:
    Aug 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Additional relevant MeSH terms:
    Ascorbic Acid
    Magnesium citrate
    Picosulfate sodium

    Study Results

    No Results Posted as of Aug 28, 2019